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PIOLAX MEDICAL DEVICES, INC.

Japan · Yokohama Kanagawa

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Hong Kong — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 2 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Import 5

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States2 registration records, 1 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: PIOLAX MEDICAL DEVICES, INC. · PIOLAX, INC., MEDICAL DEVICES DIVISION · PIOLAX MEDICAL DEVICES, Inc.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K980977	PIOLAX HYDROPHILIC GUIDEWIRE	1998-10-27
BR	81231550061	Microcateter Periférico Piolax Ponta Duplamente Angulada	Class II
BR	81231550062	MICROCATETER PERIFÉRICO PIOLAX PONTA ANGULADA	Class II
BR	81231550066	Microcateter Periférico Piolax	Class II
CA	9531	TORAY HYDROPHILIC GUIDEWIRE	Class II

PIOLAX MEDICAL DEVICES, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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